The Q-TRAK™ Subcutaneous Electrode 3400Recalls & reported problems

Summary

The FDA's MAUDE database contains 394 adverse event reports that list this exact device (DI 00802526563201), received between Jun 4, 2015 and Sep 30, 2026 — classified as 2 deaths, 317 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (146 reports).

11 other recalls cover devices cleared under the same FDA submission (P110042); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 394 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that the patient had an inappropriate shock. The patient was doing Pilates at the time of the shock. The patient has lost a significant amount of weight since the implant back in 2022. An office device check found low intrinsic amplitudes. The sensing vector was then programmed to a new sensing vector. Later, the patient wanted the system explanted due to an improvement in the ejection fraction. The doctor explanted the entire system. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50949523 ↗
• InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient had an inappropriate shock due to the oversensing of noise. The patent was sitting in a vibrating chair at the time of the shock. Technical Services reviewed the device history and found another inappropriate shock due to noise. There were some untreated episodes due to the same noise. Technical Services discussed some testing and programming options. There were no additional adverse patient effects. The system remains implanted.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50896270 ↗
• InjurySep 14, 2026High impedance; Use of Device Problem; Malposition of Device; Impedance Problem

  It was reported that this subcutaneous implantable cardioverter defibrillator (S-ICD) and electrode exhibited elevated system impedance measurement of 120 Ohms. A 10J shock was performed, and a delivered shock impedance of 124 Ohms was noted. It was noted that the S-ICD was scheduled for a routine battery replacement, and it was not possible to retrieve device data because the S-ICD was at End of Life (EOL). Technical Services (TS) reviewed next steps for the electrode included surgical revision or defibrillation threshold (DFT) testing. If DFTs were unsuccessful, the options were to surgically revise or consider a different implantable system, as it was possible this may be a higher DFT patient. Fluoroscopic imaging may also be used to look for adipose tissue. Additional information received reported that the electrode had been implanted in a suboptimal location, to the left of the sternum. Subsequently, this electrode was surgically abandoned, and a new S-ICD system was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748334 ↗
• InjuryJul 20, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD AN INAPPROPRIATE SHOCK DUE TO THE OVERSENSING OF NOISE. A REVIEW OF THE ELECTROGRAMS FOUND SIGNIFICANT RAIL-TO-RAIL NOISE. THERE WERE SOME STORED UNTREATED EPISODES DUE TO THE SAME RAILING NOISE. THE SENSING VECTOR AT THE TIME OF THE SHOCKS WAS SET TO THE PRIMARY SENSING VECTOR. THE NOISE STARTED SUDDENLY THIS PAST APRIL. THERE WERE X-RAYS DONE WHICH HAD SHADOWING WHICH CAN BE SEEN ON THE ELECTRODE AND NEAR THE EDGE OF THE ELECTRODE BODY. THE THERAPY IS NOW PROGRAMMED OFF. TECHNICAL SERVICES ADVISED SOME PROGRAMMING OPTIONS. THE PATIENT SHOULD COME BACK FOR SYSTEM PROGRAMMING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25876946 ↗
• MalfunctionJul 9, 2026Failure to Convert Rhythm; Under-Sensing

  IT WAS REPORTED THAT THE DEVICE HAD DIFFICULTY CONVERTING AN ARRHYTHMIA. THE PATIENT HAD A VENTRICULAR FIBRILLATION EPISODE WHICH REQUIRED MULTIPLE SHOCKS TO CONVERT. THERE WAS SOME UNDERSENSING POST SHOCK WHICH ADDED ABOUT TEN SECONDS TO THE TIME OF THERAPY. TECHNICAL SERVICES DISCUSSED SOME TESTING OPTIONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773144 ↗
• MalfunctionJul 8, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT A REVIEW FOR A POSSIBLE ATRIAL FIBRILLATION (AF) EPISODE WAS REQUESTED FOR THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. TS NOTED THIS S-ICD SYSTEM HAD ITS SMART PASS FEATURE DISABLED DUE TO THE PATIENTS POOR MORPHOLOGY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THE PATIENT WITH THIS S-ICD SYSTEM HAD AN ARRHYTHMIA FOR WHICH APPROPRIATE THERAPY WAS DELIVERED BUT OVERSENSING WAS NOTED DURING THE EPISODE. ADDITIONALLY, ANOTHER SHOCK WAS DELIVERED AS INAPPROPRIATE THERAPY DUE TO OVERSENSING OF THE PATIENTS SIGNALS, WITH POOR MORPHOLOGY NOTED FOR THE PATIENTS RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS THE DEVICE PROGRAMMED SETTINGS. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25749409 ↗
• InjuryJul 7, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this patient's subcutaneous implantable cardioverter defibrillator (S-ICD) was turned off and electrode disconnected due to noise from the patient's left ventricular assist device (LVAD). Per the field, the patient will be receiving a transvenous defibrillator in the upcoming months, and their S-ICD system will be taken out at that time. For now, device therapy is OFF. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742898 ↗
• MalfunctionJul 6, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS ELECTRODE RECEIVED AN INAPPROPRIATE THERAPY. SMART PASS BECAME DISABLED. REVIEW DETERMINED THAT ONE TREATED EPISODE WAS APPROPRIATE FOR A TRUE ARRHYTHMIA, WHILE ANOTHER WAS INAPPROPRIATE DUE TO OVERSENSING OF LOW-AMPLITUDE, WIDE SIGNALS. THE DEVICE WAS REPROGRAMMED TO THE SECONDARY 2X SENSING VECTOR WITH SMART PASS RE-ENABLED, AND ADDITIONAL PROGRAMMING CHANGES WERE CONSIDERED TO REDUCE FUTURE INAPPROPRIATE THERAPY. THE ELECTRO REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25728154 ↗
• InjuryJun 17, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS EXPLANTED AND REPLACED. THE SYSTEM DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE SHOCKS. THE SYSTEM ALSO EXPERIENCED T WAVE OVERSENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25536411 ↗
• MalfunctionMar 9, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED ONE SHOCK AS INAPPROPRIATE THERAPY DUE TO OVERSENSING OF NOISY SIGNALS PRODUCED WHILE THE PATIENT BRUSHED THEIR TEETH. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS PROGRAMMING OPTIONS, WITH FURTHER IN CLINIC EXAMINATION RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24548012 ↗
• MalfunctionFeb 3, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED OVERSENSING, LED TO INAPPROPRIATE ELECTRIC SHOCK. EVALUATE THE VECTOR FOR PROGRAMMING WAS RECOMMENDED. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24247334 ↗
• MalfunctionJan 28, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED AN INAPPROPRIATE ELECTRIC SHOCK DUE TO OVERSENSING. IT WAS ALSO NOTED THAT THE SMART PASS FEATURE WAS DISABLED PRIOR THIS SHOCK PER HEALTH CARE PROFESSIONAL (HCP). TECHNICAL SERVICES (TS) REVIEWED AND NOTED AF/FLUTTER EPISODES DURING SLEEP, QRS CHANGES FROM 2MV TO 1.2MV WITH WIDER COMPLEXES, AND PATIENT NOW IN FLUTTER/FIB. SMART PASS WAS RE-ENABLED, STABLE R-WAVE OBSERVED IN SLEEPING POSITION. PLAN IS CARDIOVERSION NEXT WEEK, IF AMPLITUDE RETURNS TO 2MV. AT THIS TIME THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24201795 ↗
• InjuryJan 6, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED MULTIPLE SHOCKS AS INAPPROPRIATE THERAPY. THE PATIENT EXPERIENCED SHORTNESS OF BREATH DURING THE EPISODE. ADDITIONALLY, THE DEVICES SMART PASS FEATURE WAS TURNED OFF BEFORE THE EPISODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED STORED DATA. TS DISCUSSED HOW THERE WAS OVERSENSING FOR THE PATIENT'S RHYTHM, WITH IT HAVING A WIDENED MORPHOLOGY THAT CAUSED IT TO BE OVERSENSED. TS DISCUSSED PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Shock from Patient Lead(s)

  MAUDE report 23979318 ↗
• MalfunctionDec 29, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Impedance Problem

  IT WAS REPORTED THAT THIS PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED AN INAPPROPRIATE SHOCK DUE TO WHAT APPEARED TO BE NOISE AND T WAVE OVERSENSING WITH A VERY SMALL SIGNAL. THE SMARTPASS FEATURE OF THE S-ICD WAS DISABLED. TECHNICAL SERVICES (TS) DISCUSSED TURNING SP BACK ON AND ATTEMPTING ANOTHER VECTOR. NOISE COULD NOT BE RECREATED IN CLINIC, AND THE SYSTEM IMPEDANCE WAS LOW. IT WAS QUESTIONED WHETHER THE S-ICD HAD MIGRATED, WHICH THE FIELD REPRESENTATIVE NOTED IT DID SEEM TO BE A BIT ANTERIOR. TS RECOMMENDED X RAY IMAGING. AUTOMATIC SETUP WAS UNSUCCESSFUL IN THE CURRENT VECTOR OF SECONDARY, SO PRIMARY WAS REPROGRAMMED WITH MUCH LARGER QRS COMPLEXES. THE PHYSICIAN WAS CONSIDERING DEFIBRILLATION THRESHOLD (DFT) TEST AND REVISION, HOWEVER TS REQUESTED X RAYS FIRST UNTIL THERE IS MORE INFORMATION. THERE WAS NO DFT AT THE ORIGINAL IMPLANT. AN UNTREATED EVENT WAS OBSERVED WITH SMALL AND WIDER QRS COMPLEXES, SO IT WAS QUESTIONED IF THIS PATIENT HAS ANY FLUID BUILDUP OR RATE DEPENDENT BUNDLE. THE PHYSICIAN WAS GOING TO EVALUATE THIS PATIENT FOR HEART FAILURE AND POSSIBLE FLUID. THIS ELECTRODE REMAINS IN SERVICE CURRENTLY. NO ADVERSE PAT

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23906567 ↗
• InjuryDec 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE SCHEDULED CHANGE OUT PROCEDURE FOR THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), HAD THE ASSOCIATED ELECTRODE STUCK ON ITS HEADER, WITH UNABLE TO BE REMOVED. THIS DEVICE REMAINS IN SERVICE. AT THIS TIME, THERE IS NO INDICATION A NEW SYSTEM OR DEVICE WILL BE IMPLANTED OR WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THE DEVICE REMAINS IMPLANTED, WITH THE PATIENT REFERRED TO ANOTHER FACILITY FOR REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897445 ↗
• InjuryOct 15, 2025High impedance; Impedance Problem; Material Integrity Problem; High impedance; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING IMPLANT TESTING, THE 65J SHOCK HAD AN IMPEDANCE OF 96 OHMS BUT THE 10J SHOCK IMPEDANCE WAS 125 OHMS. THE NEXT DAY THE IMPEDANCE WAS 85 OHMS WITH THE 10J SHOCK. TECHNICAL SERVICES SUSPECTS THE TISSUE INTERFACE MAY ACCOUNT FOR THE IMPEDANCE DIFFERENCES. THREE YEARS LATER, THE DOCTOR EXPLANTED THE ENTIRE SYSTEM. IT WAS REPLACED WITH A NEW PULSE GENERATOR AND ELECTRODE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279431 ↗
• InjuryAug 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS GREATER THAN 200 OHMS. THE IMPEDANCE WENT FROM 180 OHMS LAST DECEMBER UP TO 235 OHMS THIS JUNE. THE PULSE GENERATOR HAD NORMAL BATTERY DEPLETION AFTER GREATER THAN NINE YEARS OF IMPLANT TIME. SO, THE DOCTOR REPLACED THE PULSE GENERATOR ONTO THE CHRONIC ELECTRODE. THE ELECTRODE REMAINS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738803 ↗
• InjuryJul 31, 2025Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS ELECTRODE HAD AN EROSION AND INFECTION. THIS ELECTRODE WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22680508 ↗
• MalfunctionJun 20, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED ONE SHOCK AS INAPPROPRIATE THERAPY DUE T-WAVE OVERSENSING. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22299033 ↗
• MalfunctionJun 19, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED ONE SHOCK AS INAPPROPRIATE THERAPY DUE TO OVERSENSING OF NOISY SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS PROGRAMMING OPTIONS TO MITIGATE THE OVERSENSING OBSERVED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22293461 ↗
• InjuryMay 23, 2025Difficult to Remove; Defective Device; Impedance Problem; Difficult to Remove; Defective Device; Impedance Problem

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SYSTEM IMPEDANCE MEASUREMENTS. X-RAY IMAGING WERE PERFORMED. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED STORED DATA AS WELL AS X-RAY IMAGES. X-RAY IMAGES DID NOT SHOW ANY ISSUES. A REVISION WAS PERFORMED AND SOME DAMAGE WAS OBSERVED ON THE ELECTRODE WHEN EXAMINED. THERE WERE DIFFICULTIES REMOVING THE ELECTRODE, SO IT WAS DAMAGED DURING THE PROCESS. THE S-ICD SYSTEM WAS EXPLANTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079505 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ELECTRODE WAS EXPLANTED DUE TO THE PATIENT SUFFERING AN INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AND IS PENDING ANALYSIS. THE DEVICE HAS BEEN ANALYZED.

  Patient problems: Unspecified Infection

  MAUDE report 22009623 ↗
• InjuryApr 30, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED TWO SHOCKS AS INAPPROPRIATE THERAPY. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE STORED DATA, WITH T-WAVE OVERSENSING AND MORPHOLOGY CHANGES NOTED. TS DISCUSSED AVAILABLE PROGRAMMING OPTIONS, WITH IN CLINIC EXAMINATION FOR THE DIFFERENT VECTORS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21937055 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF A SYSTEM REVISION DUE TO SUTURE SLEEVE CANDIDA INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21712947 ↗
• MalfunctionMar 5, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEADLESS PACEMAKER AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM ABORTED ANTI-TACHYCARDIA PACING (ATP) DUE TO INAPPROPRIATE SENSING OF NON-PHYSIOLOGICAL SIGNALS. AS THE ATP WAS NOT DELIVERED IT WAS DETERMINED THAT THEY WOULD CONTINUE TO MONITOR AND CHECK IN AT THE NEXT SCHEDULED APPOINTMENT WITH DEVICE INTERROGATION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS S-ICD SYSTEM EXHIBITED OVERSENSING, LEADING TO INAPPROPRIATE ELECTRIC SHOCK. IT WAS NOTED THAT THE INAPPROPRIATE SHOCK CAUSED EMOTIONAL AND MENTAL DISTRESS. CURRENTLY, THIS S-ICD SYSTEM REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s); Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21527964 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P110042. One submission often covers many models, so check the product and lot details in each record.

• Z-2442-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
• Z-2441-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
• Z-0152-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
• Z-0151-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
• Z-0474-2019 · Nov 1, 2018 · Terminated
  The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for
• Z-3037-2017 · Jun 29, 2017 · Terminated
  EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatmen
• Z-3038-2017 · Jun 29, 2017 · Terminated
  EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the trea
• Z-3039-2017 · Jun 29, 2017 · Terminated
  SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias i
• Z-1178-2017 · Jan 12, 2017 · Terminated
  Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
• Z-0232-2016 · Sep 17, 2015 · Terminated
  Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
• Z-0965-2013 · Mar 1, 2013 · Terminated
  Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular t